RecruitingPHASE2INTERVENTIONAL

A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)

This study is investigating a new approach for people in the UK with a type of bladder cancer called high-risk non-muscle invasive bladder cancer (NMIBC). This means the cancer is only in the bladder lining and hasn't spread deeper. High-risk means it's more likely to come back or get worse. The usual treatment involves surgery followed by a drug called BCG, which boosts your immune system to fight the cancer. However, BCG doesn't work for everyone. Researchers want to see if adding an experimental drug, intismeran autogene, to BCG can improve treatment. Intismeran autogene is designed to help your body's immune system target your specific cancer. The study aims to find out if this combination helps people live longer and keeps their cancer from growing, spreading, or returning, compared to receiving BCG alone.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

308

Start

11 Mar 2025

Estimated completion

03 Sep 2031

Urinary Bladder Neoplasms Non-Muscle Invasive Bladder Neoplasms Carcinoma in Situ

What is this study about?

Imagine your bladder is like a balloon, and its inner lining is where this type of bladder cancer, called non-muscle invasive bladder cancer (NMIBC), starts. It hasn't grown into the balloon's muscle wall. 'High-risk' means this cancer is more likely to grow or come back after treatment. Sometimes it's a flat type of cancer called carcinoma in situ (CIS), which is also high-risk.

The standard way to treat high-risk NMIBC is to remove the tumour with a surgical procedure, then give a medicine called BCG directly into the bladder. BCG is a type of immunotherapy, which means it works by helping your body's own defence system, your immune system, fight the cancer. However, for some people, BCG doesn't completely get rid of the cancer or stop it from returning. This study is exploring if adding a new treatment called intismeran autogene to the standard BCG treatment could make it more effective. Intismeran autogene is designed to help your immune system specifically target and attack your unique cancer cells.

Researchers are hoping to learn if people who receive both intismeran autogene and BCG will stay cancer-free for longer, and if their cancer is less likely to grow, spread, or come back, compared to those who only receive BCG. This is an important step in finding better ways to manage high-risk bladder cancer and improve outcomes for patients.

Key takeaways

This study is for adults with high-risk bladder cancer that hasn't spread to the muscle.
It tests if a new drug (intismeran autogene) plus standard BCG treatment is better than BCG alone.
The goal is to see if the combination helps people live longer without their cancer growing or returning.
Participation involves regular clinic visits for treatments and health checks.
Your safety will be carefully monitored, and you can leave the study at any time.
This is a Phase 2 study, meaning it's still in early stages of testing for effectiveness and safety.

Who may be eligible?

To be considered for this study, you would generally need to be an adult (18 years or older) who has recently had surgery to remove a bladder tumour, and tests have shown you have high-risk non-muscle invasive bladder cancer. This surgery must have taken place within the last 12 weeks.

There are two main groups within the study. One group is for people who have either never had BCG treatment before or who had BCG more than two years ago and their cancer has returned. The other group might include people who have carcinoma in situ (a flat type of bladder cancer) and who can't or won't have certain other bladder treatments, or who had BCG but it didn't work for long.

Some things might mean you can't join the study. For example, if your cancer has spread beyond the bladder lining to the muscle or elsewhere in your body, or if you have other types of cancer that are growing or have needed active treatment recently. You also wouldn't be able to join if you've had a heart attack in the last six months, received certain cancer treatments recently, or have serious conditions that affect your immune system.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Have you been diagnosed with high-risk non-muscle invasive bladder cancer?
Did you have surgery to remove your bladder tumour within the last 12 weeks?
Has your cancer not spread beyond the inner lining of your bladder?
Have you not had a heart attack in the last 6 months?
Do you have good overall health, without certain serious medical conditions?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to receive either the standard BCG treatment alone or BCG along with the study drug, intismeran autogene. You will have regular visits to the clinic for treatments and check-ups. These visits will involve blood tests, physical examinations, and possibly scans or other procedures to monitor your cancer and your general health. You'll receive the study medication (if you're in that group) and BCG according to a set schedule.

The research team will closely monitor you throughout the study to track how you're responding to treatment and to check for any side effects. The total length of your participation, including follow-up visits after your main treatment, will be explained in detail by the study team. You'll receive clear instructions on what each visit involves and how long it will last.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new treatment that could be more effective than current standard care for high-risk bladder cancer, potentially reducing the chance of your cancer returning or progressing. However, like all medical treatments, there are potential risks, including side effects from the study medication or the standard BCG treatment. The research team will explain all known potential risks in detail, and your safety will be carefully monitored throughout the study. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (89)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Michael G Oefelein Clinical Trials ( Site 0138)
Verified postcode
Bakersfield, United States· Recruiting
Genesis Research, LLC ( Site 0141)
Verified postcode
Los Alamitos, United States· Active not recruiting
USC Norris Comprehensive Cancer Center ( Site 0123)
Verified postcode
Los Angeles, United States· Recruiting
Genesis Healthcare-Torrance ( Site 0140)
Verified postcode
Torrance, United States· Recruiting
Genesis Research LLC ( Site 0118)
Verified postcode
Torrance, United States· Recruiting
Urology Associates ( Site 0144)
Verified postcode
Littleton, United States· Recruiting
Urological Research Network ( Site 0133)
Verified postcode
Hialeah, United States· Recruiting
Associated Urological Specialists - Chicago Ridge ( Site 0139)
Verified postcode
Chicago Ridge, United States· Recruiting
Southern Urology, LLC ( Site 0145)
Verified postcode
Lafayette, United States· Recruiting
University of Missouri Health Care ( Site 0126)
Verified postcode
Columbia, United States· Recruiting
NHO Revive Research Institute, LLC ( Site 0137)
Verified postcode
Lincoln, United States· Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0111)
Verified postcode
New York, United States· Recruiting

Common questions

What is high-risk non-muscle invasive bladder cancer?

This is a type of bladder cancer that's only in the inner lining of your bladder and hasn't spread into the muscle wall. 'High-risk' means it has a greater chance of coming back or getting worse.

What is BCG and how does it work?

BCG is a standard treatment for this cancer. It's a medicine put directly into your bladder that helps your immune system fight the cancer cells.

What is intismeran autogene?

Intismeran autogene is a new, experimental treatment being tested in this study. It's designed to specifically help your body's immune system recognise and attack your particular cancer.

Will I definitely get the new treatment?

No, participants are randomly assigned to receive either the standard BCG treatment alone or BCG combined with intismeran autogene. You won't know which group you are in until after you've joined.

What if the treatment isn't working for me?

Your health and treatment effectiveness will be closely monitored by the study team. If the treatment isn't working or if you experience significant side effects, they would discuss your options with you, and you can withdraw at any time.

How to find out more

Toll Free Number

Trialsites@msd.com 1-888-577-8839 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.